In order to guarantee a high standard of safety and quality in gamete donations in Belgium and to strengthen the supervision of fertility centres in the long term, the Federal Agency for Medicines and Health Products (FAMHP) has drawn up a plan setting out structural improvement measures. This plan was presented to Parliament in April 2026.

During its September 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started the review of injectable iron-containing medicines. The review will assess the risk of low blood phosphate levels and related bone problems with injectable iron medicines.

Following the press articles published today concerning a new case of quota exceedance involving a foreign gamete donor, as well as the publication of the relevant information on its website, the Federal Agency for Medicines and Health Products (FAMHP) wishes to clarify the situation. The FAMHP emphasises that the identification and publication of new quota exceedances form part of the Agency’s ongoing work and reflect its commitment to transparency towards citizens.

A new guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies is now available.

The Federal Agency for Medicines and Health Products (FAMHP) is pleased to invite you to celebrate 50 years of pharmacovigilance in Belgium.

Since 1 July 2026, the use of antibiotics in all horses and aquaculture fish (intended for food production) must be recorded in the VAMREG application. The FAMHP and AMCRA are offering an e-learning course to support veterinarians with a medicinal products depot and active in these sectors in their use of this new application. A question-and-answer session is also planned.

Applicants and marketing authorisation holders can now use the new version (1.28.0.0) of the Marketing Authorisation Application Form for national, mutual recognition and decentralised procedures.

On 27 July 2026, Implementing Regulation (EU) 2026/1810 was published concerning the update of the list of essential substances for food-producing horses. This Regulation entered into force on the day following its publication and amends Implementing Regulation (EU) 2025/901 and Regulation (EC) No 1950/2006.